Quality Management System

We have implemented a total quality management system certified according to DIN EN ISO 13485, DIN EN ISO 9001 and the European legislation concerning medical devices. Of course, relevant national regulations have been taken into account as well - such as the requirements issued by the Food and Drug Administration (FDA) or the Canadian legislation.

Tokyo

The approval process for individual products may possibly not have been completed yet in your country. Please contact us for up-to-date information on the approval status of our products in your country.